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Classification of Software as a Medical device under Medical Device Regulation (European Union)

Classification of software as a Medical device under Medical Device Regulation (European Union)  The first step is to determine whether your software is a Medical Device.   How do you determine if...
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Overview of guidance and information published by the EMA and the FDA concerning the current COVID-19 epidemy

Temporary authorizations issued in response to the COVID-19 pandemic FDA enforces policy for infusion pumps and accessories during the coronavirus disease 2019 To help facilitate the availability of infusion pumps, the FDA does not intend to object to limited...
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Medical Devices under the EU´s Changing Regulatory Framework

Some of the earliest known medical devices were being used in dental procedures between 7,500-9000 years ago in a Neolithic farming community from the Mehrgarh site (Indus Valley) in what is today, western Pakistan. Excavations of the site’s graveyard point to a...
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What are the principal differences between the conformity assessment process of a medical device in the USA and in the European Union?

Figure 1: Comparison of  European and US Conformity Assessment process of Medical Devices. Adapted from European law and United States law. Copyright 2020, Kvalito Consulting Group. The difference in the conformity assessment process between the European Union...
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